In an attempt to prevent infant and child injuries and deaths, McNeil Consumer Healthcare, a Johnson & Johnson division, is recalling 43 over-the-counter child and infant medications after regulators discovered deficiencies at a manufacturing facility. Hundreds of thousands of medicine bottles will have to be pulled from store shelves in the US, its territories, and nine other nations.
Following a routine check of McNeil Consumer Healthcare’s Fort Washington plant, Food and Drug Administration inspectors discovered that the manufacturing process was “not in control,” which could alter the medicines’ composition. As a result, some of the medicines may have a higher concentration of an active ingredient than what is noted, may have inactive ingredients that don’t meet testing requirements, or may contain tiny particles.
Even though the chance of serious injury from the medicines is “remote,” the FDA is counseling caregivers and parents to stop using the recalled products right away. The FDA also says that if a child displays any unusual symptoms after taking one of the recalled medicines, then caregivers or parents should seek the advice of a physician. The federal agency is warning that giving children and infants the adult versions of these medications can result in serious illness or injury.